THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM

K043082 · Signus Medizintechnik GmbH · KWQ · Nov 23, 2004 · Orthopedic

Device Facts

• Record ID: K043082
• Device Name: THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Signus Medizintechnik GmbH
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TOSCA® Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities on curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

TOSCA® Anterior Cervical Plate System consists of bone plates and fixed or variable angle screws; used for anterior cervical fixation. Device components are implanted by surgeons via anterior approach to secure plates to cervical vertebral bodies. System provides mechanical stabilization of spine. Benefits include stabilization of spinal segments to facilitate fusion in patients with degenerative, traumatic, or deformity-related conditions. Device is non-sterile and requires surgical implantation.

Clinical Evidence

Bench testing only. Mechanical testing conducted in accordance with ASTM F1717 to verify device performance, clinical loading capacity, and mechanical integrity.

Technological Characteristics

Materials: Titanium alloy Ti64A14V conforming to ASTM F136-98. Components: Bone plates and fixed/variable angle screws. Form factor: Anterior cervical plate system. Sterilization: Supplied non-sterile. Energy source: None (mechanical fixation).

Indications for Use

Indicated for anterior cervical fixation in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• SCI Anterior Cervical Plate System (K990005)
• EBI Anterior Plate System (K943694 - K002980)

Submission Summary (Full Text)

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## NOV 2 3 2004

## SECTION 2. SUMMARY AND CERTIFICATION

## 510(k) Summary A.

| Submitter: | SIGNUS Medizintechnik GMBH<br>Brentanostr 9, Alzenau, Germany D-63755<br>Phone: [phone] |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy L. Gray RN, BS, RAC |
| Date Prepared: | November 5, 2004 |
| Trade Name: | The TOSCA® Anterior Cervical Plate System |
| Classification, Name<br>and Number: | Class II<br>21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| Product Code: | KWQ |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>The SCI Anterior Cervical Plate System (K990005), manufactured<br>by Spinal Concepts, Inc.; and The EBI Anterior Plate System (K943694 - K002980)<br>Manufactured by EBI, L.P. |
| Device Description: | The TOSCA® Anterior Cervical Plate System consists of various sizes of<br>bone plates and screws that are either fixed angle or variable angle. The<br>screws are used to secure the plates to the vertebral bodies of the cervical<br>spine though the anterior approach. The plates and screws are made from<br>Titanium alloy Ti64A14V, are in conformance with ASTM F136-98, and<br>are supplied non-sterile. |
| Intended Use: | The TOSCA® Anterior Cervical Plate System is intended for anterior<br>cervical fixation for the following indications: degenerative disc disease<br>(as defined by neck pain of discogenic origin with degeneration of the disc<br>confirmed by patient history and radiographic studies), spondylolisthesis,<br>trauma (i.e. fracture or dislocation), spinal stenosis, deformities on<br>curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor,<br>pseudoarthrosis, and failed previous fusion. |
| Functional and<br>Safety Testing: | Mechanical testing was conducted, and data collected, in accordance with<br>ASTM 1717 to ensure the device performs according to specification, to<br>verify that the device is able to withstand clinical loading and maintain<br>mechanical integrity, and is suited for its intended purpose. |
| Conclusion: | SIGNUS Medizintechnik GMBH considers the TOSCA® Anterior<br>Cervical Plate System to be equivalent to the predicate devices listed<br>above. This conclusion is based upon the devices' similarities in<br>functional design, materials, and indications for use. |

Confidential

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2004

Ms. Tracy L. Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Hwy, Suite 350 Minneapolis, Minnesota 55422

Re: K043082

Trade/Device Name: The TOSCA® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 5, 2004 Received: November 8, 2004

Dear Ms. Gray:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimered prior to rialy accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your de rise is exactional controls. Existing major regulations affecting your device can may or can been the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Tracy L. Gray

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally precred predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Mace gacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K

Device Name: The TOSCA® Anterior Cervical Plate System

Indications For Use: The TOSCA® Anterior Cervical Plate System is intended for Indications i of OSC. The TOGON - Allenter Conomic degenerative disc disease (as arnehol cervical likation for the rollowing mith degeneration of the disc confirmed by detined by neck pain of alooogenis shift min designing and trauma (i.e. fracture or patient filstory and fadiographie stadios), open in the scoliosis, kyphosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.

Prescription Use __ X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

ffice of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices 1043087 510(k) Number.

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